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NOT YET RECRUITING
NCT07754838
NA

Acoustic Stimulation to Study and Modulate Sleepwalking and Related Arousal Disorders

Sponsor: Anna Castelnovo

View on ClinicalTrials.gov

Summary

Disorders of Arousal (DoA)-such as sleepwalking, sleep terrors, and confusional arousals-are common sleep problems that happen during deep, non-dreaming sleep. Researchers do not fully understand what triggers these episodes or how to influence them. This study tests whether playing soft sounds during sleep can help researchers learn more about, and possibly induce or modulate, these episodes under safe, supervised conditions. Participants with DoA will spend two nights in the sleep laboratory, with painless sensors placed on the scalp and body (similar to a regular sleep study). On one night, no sound is played. On the other night, soft sounds are played during deep sleep. The order of the two nights is decided randomly for each participant. A small group of healthy volunteers without DoA will also take part, undergoing a single night with sound stimulation, to help researchers understand whether the sounds affect everyone the same way or specifically trigger episodes in people with DoA. A subgroup of participants with DoA will also take part in a later, exploratory step in which the sound is triggered automatically, in real time, based on brain activity patterns. The sounds used are very quiet, similar in volume to normal conversation, and stimulation is stopped right away if a participant shows any discomfort. The goal of this research is to better understand what triggers Disorders of Arousal, and to test whether sound-based stimulation could one day help study or manage this condition.

Official title: Closed-Loop and Open-Loop Acoustic Stimulation During Sleep to Investigate and Modulate Disorders of Arousal in Children and Adults

Key Details

Gender

All

Age Range

6 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-10-01

Completion Date

2030-07-30

Last Updated

2026-08-10

Healthy Volunteers

Yes

Interventions

DEVICE

Closed-Loop/Open-Loop Acoustic Stimulation (CLAS)

Brief, low-intensity auditory stimuli (pure tones or noise bursts, 50-70 dB SPL, approximately 1 second in duration) delivered via a standard speaker during confirmed slow-wave sleep (SWS). In the initial open-loop phase, stimuli are presented with randomized timing. In a later closed-loop sub-study, stimuli are triggered automatically in real time based on predefined EEG features, within randomized vulnerability versus refractory stimulation windows. Stimulation is immediately interrupted in the event of distress, full awakening, or any adverse reaction.

Locations (1)

Ospedale Italiano di Lugano

Lugano, Canton Ticino, Switzerland